MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET

Model Number 045390

Device Problems Use of Device Problem (1670); Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the basket would not close.Another device was used.There was no patient injury reported.

Event Description

It was reported that the basket would not close.Another device was used.There was no patient injury reported.

Manufacturer Narrative

The reported event was confirmed as use related.The evaluation report of the returned sample, submitted by omnitech systems, states that the lock knob that holds the control wire of the basket to the actuating thumbslide was loosened thereby making the unit inoperable.When the lock knob was torqued back to manufacturing standards, the device performed as designed.The root cause of this failure is that user was unfamiliar with the device or procedure.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "only physicians trained in stone manipulation should perform this procedure.A variety of techniques in the use of this instrument may be employed; however, the physician should use the technique with which he/she is most familiar.Inspect the device prior to use and during the procedure.Retract instrument tip into sheath.In the closed position, insert the instrument into the ureteroscope working channel and advance the ureteroscope into the ureter or renal pelvis.With the basket closed/retracted, advance the instrument to the object to be removed.Push forward on thumb control knob to advance basket between object and ureteral wall.Once the object has been captured, partially close the basket to secure the object for removal.Simultaneously withdraw the basket and the ureteroscope from the urinary system.Handle disassembly/reassembly: if handle removal is desired: unscrew the thumb screw located on the basket handle.Gently pull backward on the handle, releasing both the handle and sheath from the drivewire/basket combination.If any resistance is felt at this stage, stop and determine cause of resistance.Once the stone burden within the basket has been removed, the basket can be closed using an open tip ureteral catheter.The basket can be reassembled easily by inserting the drivewire into the sheath and advancing until it reaches the handle.Tighten the thumb screw to secure the drivewire in place." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET
• Type of Device: STONE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9417539
• MDR Text Key: 178582018
• Report Number: 1018233-2019-07746
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741066900
• UDI-Public: (01)00801741066900
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 045390
• Device Catalogue Number: 045390
• Device Lot Number: BMASMM05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1